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Opiate-Induced Tolerance & Hyperalgesia in Pain Patients

Primary Purpose

Chronic Low Back Pain, Opioid-induced Hyperalgesia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Morphine
Placebo
Sponsored by
National Institute of General Medical Sciences (NIGMS)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Low Back Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: opioid naïve (or less than 4 vicodin equiv/day) 18-70 years old candidate for opioid therapy for nonmalignant pain. Exclusion Criteria: history of substance abuse or severe psychiatric disease use of medications for the treatment of neuropathic pain as these may alter tolerance or hyperalgesia neurological conditions interfering with experimental pain testing, e.g. severe peripheral neuropathy

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

1: Placebo Pill

2: Morphine

Arm Description

This arm contains placebo medication.

Patients will receive oral morphine therapy.

Outcomes

Primary Outcome Measures

Pain Tolerance
Pain Threshold

Secondary Outcome Measures

Opioid Titration
Pain Intensity
Roland-Morris Disability Index
Beck Depression Inventory
Follow-Up Survey
Patients were asked about their average pain levels and current medication usage

Full Information

First Posted
October 26, 2005
Last Updated
April 26, 2012
Sponsor
National Institute of General Medical Sciences (NIGMS)
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1. Study Identification

Unique Protocol Identification Number
NCT00246532
Brief Title
Opiate-Induced Tolerance & Hyperalgesia in Pain Patients
Official Title
Opiate-Induced Tolerance & Hyperalgesia in Pain Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of General Medical Sciences (NIGMS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Opiates such as morphine are the cornerstone medications for the treatment of moderate to severe pain. Recent evidence suggests that pain patients on chronic opioid therapy become more sensitive to pain (hyperalgesia) over time. There is also a long-standing notion that analgesic tolerance to opioids (habituation) develops during chronic use even though this phenomenon has never been prospectively studied. Our specific aims propose to prospectively test the hypotheses that; 1) Pain patients on chronic opioid therapy develop dose-dependent tolerance and/or hyperalgesia to these medications over time, 2) Opioid-induced tolerance and hyperalgesia develop differently with respect to various types of pain, 3) Opioid-induced hyperalgesia occurs independently of withdrawal phenomena, and 4) Opioid-induced tolerance and hyperalgesia develop differently based on gender and/or ethnicity. This proposed study will be the first quantitative and prospective study of tolerance and hyperalgesia in pain patients and will have important implications for the rational use of opioids in the treatment of chronic pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain, Opioid-induced Hyperalgesia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1: Placebo Pill
Arm Type
Placebo Comparator
Arm Description
This arm contains placebo medication.
Arm Title
2: Morphine
Arm Type
Active Comparator
Arm Description
Patients will receive oral morphine therapy.
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
Patients will be given morphine sulfate oral medication until their back pain is adequately controlled.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients will receive placebo tablets.
Primary Outcome Measure Information:
Title
Pain Tolerance
Time Frame
1 month
Title
Pain Threshold
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Opioid Titration
Time Frame
1 month
Title
Pain Intensity
Time Frame
1 month
Title
Roland-Morris Disability Index
Time Frame
1 month
Title
Beck Depression Inventory
Time Frame
1 month
Title
Follow-Up Survey
Description
Patients were asked about their average pain levels and current medication usage
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: opioid naïve (or less than 4 vicodin equiv/day) 18-70 years old candidate for opioid therapy for nonmalignant pain. Exclusion Criteria: history of substance abuse or severe psychiatric disease use of medications for the treatment of neuropathic pain as these may alter tolerance or hyperalgesia neurological conditions interfering with experimental pain testing, e.g. severe peripheral neuropathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence F Chu, MD, MS
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94025
Country
United States

12. IPD Sharing Statement

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Opiate-Induced Tolerance & Hyperalgesia in Pain Patients

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